Efficacy and Safety of Standardized Extract of Trigonella foenum‐graecum L Seeds as an Adjuvant to L‐Dopa in the Management of Patients with Parkinson's Disease

The objective of this study is to evaluate disease modifying efficacy and safety of a standardized extract of Trigonella foenum‐graecum L, Fenugreek (IBHB) (family Fabaceae) as a nutritional adjuvant to Levo‐dopa (L‐Dopa) in Parkinson's disease (PD) patients. We conducted double‐blind placebo‐controlled proof of concept clinical study of IBHB capsules (300 mg, twice daily) with matching placebo for 6 months of period in 50 patients of PD stabilized on L‐Dopa therapy. The efficacy outcome measures were the scores of Unified Parkinson's Disease Rating Scale (UPDRS ‐ total and its subsections), and Hoehn and Yahr (H&Y) staging at baseline and end of 6‐months treatment duration. Safety evaluation included haematology, biochemistry, urinalysis parameters and adverse event monitoring. Total UPDRS scores in IBHB treatment (0.098%) showed slower rise as opposed to steep rise (13.36%) shown by placebo. Further, Clinically Important Difference for total UPDRS scores and scores of motor subsection of UPDRS was found to be 5.3 and 4.8, respectively, in favour of IBHB treatment. Similar improvement was shown by IBHB in terms of H&Y staging as compared with placebo. IBHB was found to have excellent safety and tolerability profile. In conclusion, IBHB can be useful adjuvant treatment with L‐Dopa in management of PD patients. Copyright © 2013 John Wiley & Sons, Ltd.     

Hyperoside Regulates the Level of Thymic Stromal Lymphopoietin through Intracellular Calcium Signalling

Hyperoside (HYP) is the principle active component of Crataegus pinnatifida. Thymic stromal lymphopoietin (TSLP) plays a vital role in the pathogenesis of allergic reactions. Here, we investigated how HYP regulates the levels of TSLP in a human mast cell line, HMC‐1 cells. We analyzed the levels of TSLP by treatment with HYP in phorbol myristate acetate plus calcium ionophore A23187‐stimulated HMC‐1 cells with ELISA and a polymerase chain reaction analysis. We also analyzed the pathway that HYP regulates TSLP by measuring the level of fluorescent intracellular calcium and using a Western blot analysis. HYP decreased the level of intracellular calcium in stimulated HMC‐1 cells. It also significantly decreased the production and mRNA expression of TSLP in stimulated HMC‐1 cells. It significantly decreased the levels of receptor‐interacting protein 2 and active caspase‐1 in stimulated HMC‐1 cells. HYP significantly decreased the translocation of NF‐κB into the nucleus and degradation of IκBα in the cytoplasm in stimulated HMC‐1 cells. Furthermore, it significantly decreased the production and mRNA expression of interleukin‐1β and interleukin‐6 in stimulated HMC‐1 cells. Taken together, our findings establish HYP as a potential agent for the treatment of allergic reactions. Copyright © 2013 John Wiley & Sons, Ltd.     

Adjuvant Therapy with Bioavailability‐Boosted Curcuminoids Suppresses Systemic Inflammation and Improves Quality of Life in Patients with Solid Tumors: A Randomized Double‐Blind Placebo‐Controlled Trial

Curcuminoids are bioactive polyphenolics with potent antiinflammatory properties. Although several lines of in vitro and preclinical evidence suggest potent anticancer effects of curcuminoids, clinical findings have not been conclusive. The present randomized double‐blind placebo‐controlled trial aimed to evaluate the efficacy of curcuminoids as adjuvant therapy in cancer patients. Eighty subjects with solid tumors who were under standard chemotherapy regimens were randomly assigned to a bioavailability‐boosted curcuminoids preparation (180 mg/day; n = 40) or matched placebo (n = 40) for a period of 8 weeks. Efficacy measures were changes in the health‐related quality of life (QoL) score (evaluated using the University of Washington index) and serum levels of a panel of mediators implicated in systemic inflammation including interleukins 6 (IL‐6) and 8 (IL‐8), TNF‐α, transforming growth factor‐β (TGFβ), high‐sensitivity C‐reactive protein (hs‐CRP), calcitonin gene‐related peptide (CGRP), substance P and monocyte chemotactic protein‐1 (MCP‐1). Curcuminoid supplementation was associated with a significantly greater improvement in QoL compared with placebo (p < 0.001). Consistently, the magnitude of reductions in TNF‐α (p < 0.001), TGFβ (p < 0.001), IL‐6 (p = 0.061), substance P (p = 0.005), hs‐CRP (p < 0.001), CGRP (p < 0.001) and MCP‐1 (p < 0.001) were all significantly greater in the curcuminoids versus placebo group. In contrast, the extent of reduction in serum IL‐8 was significantly greater with placebo versus curcuminoids (p = 0.012). Quality of life variations were associated with changes in serum TGFβ levels in both correlation and regression analyses. Adjuvant therapy with a bioavailable curcuminoid preparation can significantly improve QoL and suppress systemic inflammation in patients with solid tumors who are under treatment with standard chemotherapy protocols. Copyright © 2014 John Wiley & Sons, Ltd.     

A pilot,randomized, double‐blind,placebo‐controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee

A double‐blind, placebo‐controlled human trial was conducted to evaluate the safety and efficacy of a standardized oral supplementation of Boswellin®, a novel extract of Boswellia serrata extract (BSE) containing 3‐acetyl‐11‐keto‐β‐boswellic acid (AKBBA) with β‐boswellic acid (BBA). A total of 48 patients with osteoarthritis (OA) of the knee were randomized and allocated to the BSE and placebo groups for intervention. Patients were administered BSE or placebo for a period of 120 days. The trial results revealed that BSE treatment significantly improved the physical function of the patients by reducing pain and stiffness compared with placebo. Radiographic assessments showed improved knee joint gap and reduced osteophytes (spur) confirming the efficacy of BSE treatment. BSE also significantly reduced the serum levels of high‐sensitive C‐reactive protein, a potential inflammatory marker associated with OA of the knee. No serious adverse events were reported. This is the first study with BSE conducted for a period of 120 days, longer than any other previous clinical trial on patients with OA of the knee. The findings provide evidence that biologically active constituents of BSE, namely, AKBBA and BBA, act synergistically to exert anti‐inflammatory/anti‐arthritic activity showing improvement in physical and functional ability and reducing the pain and stiffness.     

Pycnogenol® treatment of acute hemorrhoidal episodes

We investigated the efficacy of orally and topically applied Pycnogenol^® for the management of acute hemorrhoidal attacks in a controlled, randomized study with 84 subjects. Within less than 48 h of onset of an acute attack, patients were enrolled and signs and symptoms were scored. This evaluation was repeated after seven days' treatment and again seven days following treatment cessation. The decrease in scores was significantly more pronounced in the Pycnogenol^®‐treated groups than in the control group given placebo (p < 0.05), showing the efficacy of Pycnogenol^® for relieving signs and symptoms of acute external hemorrhoids. In a group of patients given topical (0.5%) Pycnogenol^® in addition to oral Pycnogenol^® the improvement in symptoms set in significantly faster and was more pronounced. The most prominent symptom, hemorrhoidal bleeding, was completely absent in all patients treated with Pycnogenol^® for seven days and also at the 14 days follow‐up. In contrast, bleedings were still observed in the control group during the two weeks follow‐up. This study indicates that Pycnogenol^®, both in oral and in topical form, is effective for controlling this common, disabling health problem. The application of Pycnogenol^® eases the management of acute hemorrhoidal attacks and help avoid bleedings. Copyright © 2009 John Wiley & Sons, Ltd.     

A randomized, double-blind, placebo-controlled trial to evaluate efficacy and tolerability of an optimized botanical combination in the management of patients with primary hypercholesterolemia and mixed dyslipidemia

This study compared the efficacy and tolerability of an optimized botanical combination containing policosanol, tomato extract, orally bioavailable grape procyanidins and Oenothera biennis oil against placebo in the management of patients with primary hypercholesterolemia and mixed dyslipidemia. Such a combination is endowed with biological properties targeted to cholesterol control and vasoprotection. This randomized, double‐blind, parallel‐group trial consisted of a 6 week treatment period following 4 week baseline period, and a 2 week post‐treatment follow‐up. At baseline, both the groups were comparable to each other. Both the active treatment and the placebo group included 30 patients (active treatment: mean age 46.80 ± 7.43 years, nine males; placebo: mean age 45.50 ± 6.76 years, eight males). Significant reductions in the LDL‐cholesterol (LDL‐C; ?17.33% from baseline, p < 0.001) and total cholesterol (TC; ?13.38% from baseline, p < 0.0001) values over the treatment period were observed with the tested product. The treatment also resulted in reductions in C‐reactive protein (CRP), malondialdehyde (MDA) and superoxide dismutase (SOD) values, which are indices of oxidative stress. This rational combination of different compounds is effective and safe in lowering the elevated LDL‐C and TC values. It is also effective in the modulation of the oxidation indices values; however, a further long term study in a larger population would be needed in order to confirm these preliminary findings. Copyright © 2011 John Wiley & Sons, Ltd.     

Quality of Life,Mental Health,Personality and Patterns of Use in Self‐Medicated Cannabis Users with Chronic Diseases: A 12‐Month Longitudinal Study

The number of patients using cannabis for therapeutic purposes is growing worldwide. While research regarding the treatment of certain diseases/disorders with cannabis and cannabinoids is also expanding, only a few longitudinal studies have assessed the mid‐term impacts of medical cannabis use on psychological variables and quality of life (QoL). The aim of the study was to assess the psychological safety and QoL of patients with chronic diseases who self‐medicate with cannabis over time. We recruited patients with various chronic diseases who use cannabis and collected data regarding patterns of cannabis use as well as mental health, personality and QoL. Participants were followed‐up at baseline, 4, 8 and 12 months. Hair analysis was conducted to confirm the presence of cannabinoids. Personality assessment showed a consistent decrease in self‐transcendence and self‐directedness scores. Neither cognitive nor psychopathological deterioration was found. There were also no variations in QoL. Mid‐term use of medical cannabis seems to show adequate tolerability regarding cognitive and psychopathological abilities, and it may help patients with chronic diseases to maintain an acceptable QoL.     

Randomized double‐blind placebo‐controlled trial on the potential modes of action of sheaflex70tm in osteoarthritis

Extracts from the seed of the African shea tree Vitellaria paradoxa C.F. Gaertn have been used traditionally for the treatment of arthritic conditions. However, little is known about the mechanisms by which benefit is conferred. This single‐site, 15‐week randomized, double‐blind, parallel, placebo‐controlled study examined a range of biomarkers in 89 patients with osteoarthritis of the knees and/or hips to determine potential modes of action of SheaFlex70^TM, a triterpene‐rich extract of Vitellaria paradoxa. In the group of participants with levels of osteoarthritis biomarkers in the upper quartile at baseline, there were significant decreases in inflammation and cartilage breakdown and trend level decreases in bone remodeling in the SheaFlex70^TM group versus placebo between commencement and completion of the study. Inflammation marker TNF‐alpha fell 23.9% vs 6% (treatment vs placebo), p = 0.041. Cartilage degradation marker CTX‐II fell 28.7% vs an increase of 17.6% (treatment vs placebo), p = 0.018. This marker also showed significant falls across the entire study group, 10.6% vs an increase of 11.6%, (treatment vs placebo), p = 0.016. Osteocalcin levels fell 9.2%, p = 0.014 (treatment) vs 1.2%, ns (placebo), p = 0.096 (treatment vs placebo). These findings indicate that in patients with the highest levels of osteoarthritis biomarkers, SheaFlex70^TM demonstrated multiple beneficial activities consistent with slowing the disease process. Copyright © 2009 John Wiley & Sons, Ltd.     

Efficacy and tolerability of a standardized willow bark extract in patients with osteoarthritis: randomized placebo-controlled, double blind clinical trial.

This study assessed the clinical efficacy of a chemically standardized willow bark extract in the treatment of osteoarthritis. Willow bark extract, in a dose corresponding to 240 mg salicin/day, was compared with placebo in a 2-week, double-blind, randomized controlled trial. The primary outcome measure was the pain dimension of the WOMAC Osteoarthritis Index. Secondary outcome measures included the stiffness and physical function dimensions of the WOMAC, daily visual analogue scales (VAS) on pain and physical function, and final overall assessments by both patients and investigators. A total of 78 patients (39 willow bark extract, 39 placebo) participated in the trial. A statistically significant difference between the active treatment and the placebo group was observed in the WOMAC pain dimension (d = 6.5 mm, 95% C.I. = 0.2-12.7 mm, p = 0.047); the WOMAC pain score was reduced by 14% from the baseline level after 2 weeks of active treatment, compared with an increase of 2% in the placebo group. The patient diary VAS confirmed this result, and likewise the final overall assessments showed superiority of the willow bark extract over the placebo (patients' assessment, p = 0.0002; investigators' assessment, p = 0.0073). It is concluded that the willow bark extract showed a moderate analgesic effect in osteoarthritis and appeared to be well tolerated.     

Efficacy of black seed (Nigella sativa L.) on kidney stone dissolution: A randomized,double‐blind,placebo‐controlled,clinical trial

Preclinical studies have shown beneficial effects of black seed (Nigella sativa L.) in the prevention and treatment of renal stones. Hence, we designed a study to evaluate the renal‐stone‐dissolving efficacy of black seed. Sixty patients with renal stones were randomly enrolled in two arms of a randomized, triple‐blind, placebo‐controlled, clinical trial. The patients were treated by black seed capsules (500 mg) or placebo two times per day for 10 weeks. Patients were assessed in terms of size of renal stones by using sonography before and after intervention. In the black seed group, 44.4% of patients excreted their stones completely, and the size of the stones remained unchanged and decreased in 3.7% and 51.8% of patients, respectively. In contrast, in the placebo group, 15.3% of the patients excreted their stones completely, 11.5% had reduction in stone size, 15.3% had increase in stone size, and 57.6% had no change in their stone size. The difference in the mean size of renal stones after the study was significant between the two groups (p < 0.05). N. sativa L., as compared with placebo, is demonstrated to have significant positive effects on disappearance or reduction of size of kidney stones.     

Ginger for Prevention of Antituberculosis‐induced Gastrointestinal Adverse Reactions Including Hepatotoxicity: A Randomized Pilot Clinical Trial

In this study, the potential benefits of ginger in preventing antituberculosis drug‐induced gastrointestinal adverse reactions including hepatotoxicity have been evaluated in patients with tuberculosis. Patients in the ginger and placebo groups (30 patients in each group) received either 500 mg ginger (Zintoma)^® or placebo one‐half hour before each daily dose of antituberculosis drugs for 4 weeks. Patients' gastrointestinal complaints (nausea, vomiting, dyspepsia, and abdominal pain) and antituberculosis drug‐induced hepatotoxicity were recorded during the study period. In this cohort, nausea was the most common antituberculosis drug‐induced gastrointestinal adverse reactions. Forty eight (80%) patients experienced nausea. Nausea was more common in the placebo than the ginger group [27 (90%) vs 21 (70%), respectively, p = 0.05]. During the study period, 16 (26.7%) patients experienced antituberculosis drug‐induced hepatotoxicity. Patients in the ginger group experienced less, but not statistically significant, antituberculosis drug‐induced hepatotoxicity than the placebo group (16.7% vs 36.7%, respectively, p = 0.07). In conclusion, ginger may be a potential option for prevention of antituberculosis drug‐induced gastrointestinal adverse reactions including hepatotoxicity. Copyright © 2016 John Wiley & Sons, Ltd.     

Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339

BACKGROUND: Intermittent allergic rhinitis (IAR) causes patients distress and impairs their work performance and quality of life. A variety of medicines are used by sufferers whose anguish frequently leads to trying new treatments, increasingly from herbal sources. METHODS: Prospective, randomized, double-blind, parallel group comparison study of Butterbur extract (Ze 339; 8 mg total petasine; one tablet thrice-daily), fexofenadine (Telfast 180, one tablet once-daily) and placebo in 330 patients. Protocol and analysis were according to the latest guidelines on new treatments for allergic rhinitis. The primary efficacy variable was a change in symptoms from baseline to endpoint during daytime. The secondary efficacy variables were: (a) as per primary variable (evening/night); (b) Physician's global assessment; (c) Responder rates. Safety was closely monitored. FINDINGS: Both active treatments were individually significantly superior to placebo (p<0.001) in improving symptoms of IAR, while there were no differences between the two active treatments (p=0.37). Superiority to placebo was similarly shown during the evening/night (p<0.001), by physicians' own assessment and by responder rates. Both treatments were well tolerated. INTERPRETATION: Butterbur Ze 339 and Fexofenadine are comparably efficacious relative to placebo. Despite being a herbal drug, Butterbur Ze 339 has now been subject to a series of well controlled trials and should be considered as an alternative treatment for IAR.     

Combination of Comfrey Root Extract Plus Methyl Nicotinate in Patients with Conditions of Acute Upper or Low Back Pain: A Multicentre Randomised Controlled Trial

This randomised, multicentre, double‐blind, three‐arm, placebo‐controlled trial compared a topical combination of 35% comfrey root extract plus 1.2% methyl nicotinate versus a single preparation of methyl nicotinate or placebo cream for relief of acute upper or low back pain. 379 patients were randomly assigned to three groups (combination, n = 163; methyl nicotinate, n = 164; placebo, n = 52). They applied a 12 cm layer of cream three times daily for 5 days. The primary efficacy variable was the area under the curve (AUC) of the visual analogue scale (VAS) on active standardised movement values at visits 1 to 4. Secondary measures included back pain at rest, pressure algometry, consumption of analgesic medication, functional impairment measured with Oswestry Disability Index, and global assessment of response. The AUC of the VAS on active standardised movement was markedly smaller in the combination treatment group than in the methyl nicotinate and in the placebo group (ANOVA: p < 0.0001). The combination demonstrated superiority to the two other treatment arms, while methyl nicotinate displayed a considerable effect as well. Copyright © 2012 John Wiley & Sons, Ltd.     

The beneficial health effects of Nigella sativa on Helicobacter pylori eradication,dyspepsia symptoms,and quality of life in infected patients: A pilot study

The aim of this study was to evaluate the effects of Nigella sativa (N. sativa) in addition to quadruple‐therapy on Helicobacter pylori eradication, dyspepsia, biochemical‐markers, and quality of life in infected patients. In this double‐blind placebo‐controlled clinical‐trial, 51 H. pylori infected patients with functional dyspepsia were randomly assigned to treatment (quadruple‐therapy with 2 g/day N. sativa) or placebo groups (quadruple‐therapy with 2 g/day placebo) for 8 weeks. Serum levels of interleukin‐8 (IL‐8), high‐sensitivity C‐reactive protein (hs‐CRP) and malondialdehyde, quality of life, dyspepsia, food‐intake, body‐weight, and body mass index (BMI) were evaluated at the baseline and at the end of the study. H. pylori eradication was evaluated at the end of the intervention. At the end of the study, H. pylori eradication was more in the N. sativa group compared with the placebo (p = .01). Weight, BMI, and dietary‐intake (p < .05) increased significantly as compared with placebo. A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05). The differences of biochemical‐markers and dyspepsia between the two groups were not significant. So, N. sativa supplementation with medical treatment may have beneficial effects on H. pylori eradication, weight, BMI, dietary‐intake, and quality of life in infected patients.     

Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: randomized,placebo‐controlled pharmaco‐clinical trial

Herbal drugs are often used in patients with somatoform disorders yet, the available evidence is limited. The aim of the present short‐term study was to evaluate in a pharmaco‐clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185 = 4‐combination versus 3‐combination without butterbur and placebo) in patients with somatoform disorders. For a 2‐week treatment in patients with somatization disorder (F45.0) and undifferentiated somatoform disorder (F45.1), 182 patients were randomized for a 3‐arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo). Anxiety (visual analogue scale – VAS) and depression (Beck's Depression Inventory – BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter. The 4‐combination was significantly superior to the 3‐combination and placebo (4‐combination > 3‐combination > placebo) in all the primary and secondary parameters (PP‐population). Analysis of the ITT population confirmed these results. As to safety, no serious adverse events occurred. In total 9 non‐serious adverse events were documented but the distribution did not differ significantly between the treatment groups. This herbal preparation (Ze185) showed to be an efficacious and safe short‐term treatment in patients with somatoform disorders. Copyright © 2009 John Wiley & Sons, Ltd.     

Three‐arm,placebo‐controlled,randomized clinical trial evaluating the metabolic effect of a combined nutraceutical containing a bergamot standardized flavonoid extract in dyslipidemic overweight subjects

Our double‐blind, placebo‐controlled, parallel‐group, dose‐escalation, clinical trial aimed to test the effect of a combined nutraceutical containing bergamot extract (120‐mg flavonoids), phytosterols, vitamin C, and chlorogenic acid from dry artichoke extract on 90 overweight dyslipidemic subjects. Participants were randomly allocated to treatment with two pills of either active treatment or placebo, or a combination of both (a pill per treatment). After 8 weeks, all active‐treated groups experienced a significant improvement in triglycerides (TG) versus placebo and in low‐density lipoprotein cholesterol (LDL‐C) versus baseline and placebo treatments. In the high‐dose‐treated group, also total cholesterol (TC), nonhigh‐density lipoprotein cholesterol (non‐HDL‐C), γ‐glutamil transpeptidasi, high‐sensitivity C‐reactive protein (hs‐CRP), and tumor necrosis factor‐α (TNF‐α) significantly decreased. At 24‐week follow‐up, TG levels maintained lower than baseline in all groups. All patients allocated to either low‐dose or high‐dose active treatment experienced a significant decrease in TG, LDL‐C, and homeostatin model assessment of insulin resistance. In subjects taking high‐dose active treatment, adiponectin significantly increased, whereas TC, non‐HDL‐C, insulin (fasting plasma insulin), leptin, leptin/adiponectin ratio, hs‐CRP, and TNF‐α were significantly reduced. The tested nutraceutical showed to improve lipid and glucose metabolism, adipokines pattern, and systemic inflammation in dyslipidemic overweight subjects.     

Effect of pine bark extract (Pycnogenol) on symptoms of knee osteoarthritis

Objective. The safe and efficacious use of Pycnogenol^® (French maritime pine bark extract) in other inflammatory diseases prompted this study of its antiinflammatory effects in patients with osteoarthritis (OA). The aim of the study was to evaluate whether Pycnogenol^® reduces the symptoms of OA in a double‐blind, placebo‐controlled, randomly allocated trial with patients suffering from knee osteoarthritis stages I and II. Methods. 100 patients were treated for 3 months either by 150 mg Pycnogenol^® per day at meals or by placebo. Patients had to report any change of use of previously prescribed antiinflammatory medication during the study period. Patients filled the Western Ontario and Mc Masters University (WOMAC) questionnaire for osteoarthritis every 2 weeks and evaluated weekly pain symptoms using a visual analogue scale for pain intensity. Results. Following treatment with Pycnogenol^® patients reported an improvement of WOMAC index (p < 0.05), and a significant alleviation of pain by visual analogue scale (p < 0.04), the placebo had no effect. The use of analgesics diminished in the verum group but increased under the placebo. Treatment with Pycnogenol^® was well tolerated. Conclusion. Results show that Pycnogenol^® in patients with mild to moderate OA improves symptoms and is able to spare NSAIDs. Copyright © 2008 John Wiley & Sons, Ltd.     

A double-blind, placebo-controlled investigation of the effects of Passiflora incarnata (passionflower) herbal tea on subjective sleep quality

Passiflora incarnata is a traditional herbal sedative, anxiolytic and a popular sleep aid used for the treatment of sleep disturbance. Several controlled experiments have demonstrated enhanced sleep in laboratory animals, but clinical trials in humans are lacking. The aim of the present study was to investigate the efficacy of Passiflora incarnata herbal tea on human sleep, as measured using sleep diaries validated by polysomnography (PSG). This study featured a double‐blind, placebo‐controlled, repeated‐measures design with a counterbalanced order of treatments (passionflower vs placebo tea), separated by a 1 week ‘washout’ period. Forty‐one participants (18–35 years) were exposed to each treatment for a week, whereby they consumed a cup of the tea and filled out a sleep diary for 7 days, and completed Spielberger's state‐trait anxiety inventory on the seventh morning. Ten participants also underwent overnight PSG on the last night of each treatment period. Of six sleep‐diary measures analysed, sleep quality showed a significantly better rating for passionflower compared with placebo (t(40) = 2.70, p < 0.01). These initial findings suggest that the consumption of a low dose of Passiflora incarnata, in the form of tea, yields short‐term subjective sleep benefits for healthy adults with mild fluctuations in sleep quality. Copyright © 2011 John Wiley & Sons, Ltd.     

Efficacy of topical Citrullus colocynthis (bitter apple) extract oil in chemotherapy‐induced peripheral neuropathy: A pilot double‐blind randomized placebo‐controlled clinical trial

Chemotherapy‐induced peripheral neuropathy (CIPN) is one of the most common complications in patients with cancer. Citrullus colocynthis (bitter apple) has been used in traditional Persian medicine as an effective pain relief, especially for neuralgia. We designed a pilot clinical trial to evaluate the safety and efficacy of topical C. colocynthis oil in management of CIPN in breast cancer patients. Thirty‐four cancer patients with CIPN were randomly enrolled in two arms of a randomized, double‐blind, placebo‐controlled clinical trial. The patients were treated by topical C. colocynthis oil or placebo, two times per day for 2 months. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)‐Neurotoxicity (Ntx) score was set as the primary outcome measure. No significant improvement was observed in the total score of FACT/GOG‐Ntx scale (2.40 ± 1.90 vs. 1.05 ± 1.36, p = .879) in drug and placebo groups, respectively. There was also no significant improvement in the mean scores of FACT/GOG‐Ntx in the sensory, motor, hearing, and functional domains in the two study groups. According to the results of this preliminary study, topical C. colocynthis oil failed to improve the symptoms of CIPN compared with placebo.